A Pleasanton firm that received FDA approval for a test against cervical cancer said it has gained the support of a panel of medical experts to use the test as a frontline screening for women as young as 25, but the announcement only reopened the debate of whether the mainstay of women's health, the Pap smear, will become a thing of the past.
The Food and Drug Administration in April approved the cobas HPV test, which is manufactured by Roche Molecular Systems. Last week, new guidelines for cervical cancer screening were issued by two medical societies, the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology, both of which back the use of the test instead of the Pap smear - or to be used with the Pap smear.
The developments have caused some to ask: Could the HPV test do away with the Pap smear all together?
"I think it's headed in that direction," said Dana Chase, a gynecologic oncologist at St. Joseph's Hospital and Medical Center in Phoenix after a forum sponsored by Roche in Pleasanton earlier this week at which she was paid by Roche to speak. "We've needed something better for a long time. The Pap smear is an old test. It's been around since the 1940s. But we're not quite there. This is the first step."
A recent study by Roche of 47,000 women found the test was more effective at predicting risk of cervical cancer than a Pap test alone, and there was an unexpectedly high incidence of cervical disease in women ages 25 to 29, Chase explained, which led a panel of experts from seven medical societies to issue the new guidelines.
But Diana Zuckerman, president of the Cancer Prevention and Treatment Fund in Washington, D.C., said the study's results were misrepresentative because the study did not sample enough women. She said current guidelines, which give women 30 and older the option of having the Pap smear alone every three years or the HPV test with the Pap smear every five years, are more appropriate because testing women at younger ages, 25 to 29, when they tend to be most sexually active, could lead to too many false alarms.
Some 80 percent of women will have an HPV infection by age 50, according to the Centers for Disease Control and Prevention. More than 90 percent of all HPV infections are cleared by the body's immune system within two years without causing any serious health problems. Many women, especially those in their 20s, carry HPV, the human papillomavirus, and most will never know it because it doesn't transform into anything serious, according to the CDC.
"For the vast majority, it will go away by itself over time like the common cold," Zuckerman said.
"The reason that early HPV testing is so dangerous is that what will happen is there will be a lot of women with HPV in their 20s who will be frightened by the results, who would have never gotten cancer anyway, but because they get this test, they will get other tests," she said.
These include more invasive procedures, such as a colposcopy, a test to find abnormal cells on the cervix, which are expensive, painful and could interfere with a patient's fertility if done too often, she said.
About 12,900 new cases of invasive cervical cancer are expected to be diagnosed this year, with 4,100 of them fatal due to a lack of Pap smear screening, according to the American Cancer Society. Cervical cancer was once one of the most common causes of cancer deaths for American women. But over the past 30 years, the death rate has declined more than 50 percent, mainly due to the increased use of the Pap test.
However, Chase said 99.9 percent of cervical cancers are caused by HPV, and the new HPV test is sensitive enough to detect the most high risk of HPV strains, such as HPV 16 and 18, which have the highest chance of developing into cervical cancer.
Heather Banks, 39, an elementary school teacher from Indianapolis who also was paid to speak at the Roche forum, said she'd had 13 consecutive years of clean Pap smears before she discovered she had cervical cancer after her second child was born in 2008.
She said if she'd known she had high risk HPV earlier, it's possible her cervical cancer, which led to a hysterectomy and early menopause, wouldn't have progressed so far.
"It's amazing how little I knew about HPV. I knew next to nothing, and the only thing I could do was react to it," she said. "We want to educate and empower women to be aware of their options."
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